April 10, 2020 - Fierce Pharma
Amneal, one of many drugmakers pledging millions of tablets of COVID-19 therapy hopeful hydroxychloroquine, is facing an ingredients shortage after the Finnish government locked down exports of the drug.
Meanwhile, WHO is warning governments that lifting lockdowns could increase COVID-19 infections and cause a "deadly resurgence" of the disease in areas where new infections have flattened.
April 9, 2020 - Fierce Biotech
There’s more than one way to skin a cat. And in the race to create a plasma-based treatment for COVID-19, industry leaders have decided the best way is to join forces. Takeda and CSL Behring have
set up an alliance
to ramp up the development of such a treatment, joined by other plasma players hailing from the U.K., Switzerland, Germany and France.
The group will work on a treatment made from the plasma of patients who have recovered from COVID-19. Known as hyperimmune immunoglobulins, these drugs are made by purifying antibodies from donated plasma. Takeda had been working on TAK-888, a polyclonal hyperimmune globulin (H-IG) against SARS-CoV-2, the virus that causes COVID-19, but the partners will now focus their efforts on a single, unbranded medicine.
April 8, 2020 - BioPharma Dive
Roche will pay privately held Arrakis Therapeutics $190 million in a
to co-develop small molecule drugs that target RNA molecules.
Cambridge, Massachusetts-based Arrakis will handle the early drug development work, after which Roche can license those that show promise and take the lead on clinical testing. The deal includes a variety of conditional payments that could ultimately exceed "several billion dollars," though that cash is tied to milestones and may never materialize.
Arrakis is one of several emerging companies aiming to target shifty RNA molecules with chemical drugs. Their approach offers the potential to reach drug targets inside cells that are difficult to get at through other methods.
April 7, 2020 - Fierce Pharma
Roche has stepped on the gas in testing Actemra for coronavirus patients, thanks to a little more help from the U.S. government.
With $25 million in backing from the U.S. Biomedical Advanced Research and Development Authority (BARDA), the Swiss drugmaker will speed up Actemra's phase 3 trial in COVID-19 patients, the agency said Tuesday.
The BARDA grant is part of an expanded partnership Roche's Genentech signed with the agency to accelerate clinical trials of Actemra, an IL-6 inhibitor that could help fend off the severe lung inflammation that hits some patients.
April 6, 2020 - Fierce Biotech
Vir Biotechnology is adding GlaxoSmithKline to its roster of COVID-19 partners—and snagging a $250 million investment in the process. The duo will pool their resources to
develop vaccines and treatments
for coronaviruses, starting with two antibodies against SARS-CoV-2, the virus behind the current pandemic, which could hit phase 2 studies as early as this summer.
The pair's immediate focus will be VIR-7831 and VIR-7832, a pair of antibodies identified by Vir’s monoclonal antibody technology that bind tightly to the spike protein of the novel coronavirus. They plan to move the candidates into a phase 2 clinical trial in the next three to five months—subject to regulatory review, of course.
The deal goes beyond just the current pandemic. It includes work to identify antiviral antibodies for preventive and therapeutic use in future outbreaks as well as the COVID-19 outbreak. The partners will also combine their CRISPR screening and artificial intelligence capabilities, along with GSK’s functional genomics know-how, to pinpoint new anti-coronavirus compounds. They’re looking for targets inside cells that, if inhibited, could prevent viral infection—something Vir has done with other viruses such as influenza and hepatitis B.